ACTIVE PHARMACEUTICAL INGREDIENTS – MADE IN GERMANY

Arevipharma puts focus on the process development of stable and robust chemical synthesis routes, and its quality management to ensure its Active Pharmaceutical Ingredients (API) are of the highest quality.

Controlled quality

Accuracy and reliability distinguish the analytical results of quality control. The quality of API manufactured by Arevipharma has sealed their good reputation among customers. Row materials, intermediates, API and primary packaging are checked in accordance to specification and communicated and professionally documentated in an efficient manner.
Arevipharma develops, validates and transfers new methods of analysis, this is done also in the field of trace analysis, e.g. for potential genotoxic substances. Thorough reporting is included, of course. The Quality control department carries out structural elucidation of by-products and degradation products, quality control qualifies reference substances and performs API stability tests according to international guidelines.

Ensure quality – assume responsibility

Inspections by the following authorities have confirmed Arevipharma’s GMP compliance:

The State Directorate of Saxony (Landesdirektion Sachsen) (GMP certification)

The U. S. Food and Drug Administration (FDA)

The Korean Food and Drug Administration (KFDA)

The Japanese Authority for Medicinal Products and Medical Devises (PMDA)

The Brazilian Authority responsible for health surveillance (ANVISA)

The department Regulatory Affairs is responsible for compiling and keeping up-to-date globally issued regulatory API dossiers, it also provides our customers with all information and data required.

Its effective system for quality management helps Arevipharma to guarantee its products meet Arevipharma’s highest demands on quality. The system complies with the current requirements of the Pharmaceuticals and Active Agent Manufacturing Ordinance (AMWHV) as well as the international regulations of Good Manufacturing Practice (GMP) according to ICH Q7 and the implementation of these regulations in the EU member states (EU GMP guide part II) and in the Unites States of America (21 CFR 210 & 211), respectively.

Our service: contracted analyses

At Arevipharma highly qualified staff analyse chemical and pharmaceutical intermediates and API supported by extensive analytical equipment at the highest possible technical level. Analysis results are documented in accordance with national and international standards and regulations. Efficient processes enable the quality control team to respond flexibly to requests and to deliver excellent quality even for short-term orders.